Reported Mar 8, 2023 · Terminated

Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC…

Accord Healthcare, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

    • Pravastatin Sodium Tablets USP 20 mg
    • Rx Only
    • 90-count bottle
  • Manufactured forAccord Healthcare, Inc., Durham
  • NC 27703 Manufactured by
    • Intas Pharmaceuticals Limited
    • Pharmez
    • Ahmedabad-382 213
    • INDIA. NDC 16729-009-15
    • UPC 3 16729 00915 7
Lot codes and dates
  • Batches
    • a )R2200589
    • R2200689
    • R2200690
    • R2201232
    • Exp. Date 4/30/2024
Amount recalled
32,688 bottles

This recall covers 67 products

The agency filed one notice per product. You are reading one of them; the other 66 are below.

54 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 8:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.